BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLUM XLD SPANISH

    MDR report key: 4345394 · Received December 5, 2014

    Report

    Report Number
    9615050-2014-06360
    Event Type
    Malfunction
    Date Received
    December 5, 2014
    Date of Event
    November 17, 2014
    Report Date
    November 17, 2014
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FRN
    PMA / PMN Number
    K010924
    Removal / Correction Number
    FA311-04
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TESTING AND INVESTIGATION FOUND THAT THE DEVICE DOOR ROLLER WAS BROKEN OFF. FURTHER TESTING FOUND THE FRONT CASE AND THE CONTROL KOB POSITION WERE DAMAGED. THE CONTROL KNOB POSITION DOES MATCH THE DISPLAYED POSITION AND THE DEVICE IS PROGRAMMABLE. THIS WAS DUE TO USE IN THE CUSTOMER ENVIRONMENT. AS INDICATED, THE DEVICE HAS BEEN IDENTIFIED AS PART OF A PRODUCT RECALL. THIS REPORT REPRESENTS ALL THE INFORMATION KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED THE DEVICE DOOR ROLLER PIN WAS BROKEN. THERE WERE NO REPORTS OF ANY ADVERSE PATIENT EVENTS OR DELAYS IN CRITICAL THERAPIES WHILE THE DEVICE WAS IN CLINICAL USE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    786035 PLUM XLD SPANISH 80FRN FRN HOSPIRA COSTA RICA LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA